Incontinence pads are medical devices that have the function of absorbing and retaining the urine and stool of incontinent people while keeping their skin healthy and dry. Since the 1980s, the incontinence market has developed considerably, due to the increase in the number of dependent people, an increased tendency to stay at home, or even a reduction in the stigmatization associated with these products.
In 2018, ANSES received a request from the Directorate General for Health and the Directorate General for Competition, Consumer Affairs and Fraud Prevention in order to assess the safety of these protections in terms of the risk of allergy, infections or intolerance, and chemical risks, by skin contact or by contact with the mucous membranes.
Several chemicals found in incontinence pads exceed health thresholds for skin lesions
Tests carried out on four references marketed in 2017-2018 for protections for heavy incontinence revealed the presence of various dangerous chemical substances (dioxins, furans and PCB-DL and formaldehyde). They would come from the contamination of the raw materials or the manufacturing processes used. These substances can in particular migrate into the urine and come into prolonged contact with the skin. The risk assessment carried out by ANSES concluded that, as long as the skin remains healthy, the health thresholds are not exceeded.
On the other hand, in view of the exceeding of the health thresholds for some of the substances, the expertise shows that wearing these protections over the long term – duration of continuous wear of more than 1 year – can lead to a health risk for populations, “elderly » or « young people », suffering from lesions of the skin at the level of the seat. However, when the port is prolonged or almost continuous, the risk of appearance of such lesions is increased.
ANSES’s recommendations: limit chemical substances in incontinence pads and prevent the appearance of skin pathologies in users
In view of the results of this expert appraisal, ANSES recommends:
- to manufacturers of incontinence pads:
- to eliminate the use of all fragrant substances in the composition of incontinence pads, in priority those with irritating and sensitizing effects on the skin;
- to better control the origin of natural raw materials that may be contaminated, even before manufacturing;
- to improve the manufacturing processes in order to reduce as much as possible the presence of undesirable chemical substances in the materials constituting the complete diapers;
- to better document the nature of the raw materials making up these products and display them on the packaging in order to inform users.
- to public authorities:
- to monitor the presence of hazardous substances in incontinence pads through measurement campaigns on all products on the market;
- facilitate access to the exact and detailed composition of products for healthcare professionals, in the context of materiovigilance.
- to health professionals, accompanying persons or users:
- to ensure compliance with good practices for the use of protections (frequent changes, cleaning and drying of the skin, etc.) to minimize the risk of skin alteration at the level of the seat;
- to notify the adverse effects related to the wearing of protection for incontinence to the National Agency for the Safety of Medicines in the Portal dedicated to reporting adverse health events.
